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| Name | Class |
|---|---|
| Boryung Pharmaceutical Co., Ltd | INDUSTRY |
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The primary objectives of this study is to compare the efficacy of paclitaxel monotherapy with irinotecan monotherapy as defined by progression-free survival (PFS), in all patients with recurrent and metastatic gastric cancer who progress following first line therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| paclitaxel | Experimental | Paclitaxel 70 mg/m2 on Days 1, 8 and 15 of a 28-day cycle |
|
| irinotecan | Experimental | irinotecan 150 mg/m2 on Days 1 and 15 of a 28-day cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel | Drug | Paclitaxel, 70 mg/m2 will be administered as an intravenous (IV) infusion over 1 hour on Days 1, 8 and 15 of a 28-day cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival | Tumor evaluation using RECIST v1.1 | every 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Number of Participants and toxicity grade accordong to NCI-CTCAE v3.0 as a Measure of Safety | up to 4 weeks after last administration of chemotherapy |
| Overall survival | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tae-You Kim, M.D., Ph.D. | Contact | 82-2-2072-3943 | kimty@snu.ac.kr | |
| Jae Yong Cho, M.D., Ph.D. | Contact | 82-2-2019-4363 | chojy@yuhs.ac |
| Name | Affiliation | Role |
|---|---|---|
| Tae-You Kim, M.D., Ph.D. | Korean Cancer Stusy Group stomach Cancer Committee | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei University Gangnam Severance Hospital | Recruiting | Seoul | 135-720 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30126861 | Derived | Lee KW, Maeng CH, Kim TY, Zang DY, Kim YH, Hwang IG, Oh SC, Chung JS, Song HS, Kim JW, Jeong SJ, Cho JY. A Phase III Study to Compare the Efficacy and Safety of Paclitaxel Versus Irinotecan in Patients with Metastatic or Recurrent Gastric Cancer Who Failed in First-line Therapy (KCSG ST10-01). Oncologist. 2019 Jan;24(1):18-e24. doi: 10.1634/theoncologist.2018-0142. Epub 2018 Aug 20. |
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| Irinotecan | Drug | irinotecan 150 mg/m2 will be administered as an intravenous (IV) infusion over 1 hour on Days 1 and 15 of a 28-day cycle |
|
| Seoul National University Hospital | Recruiting | Seoul | South Korea |
|
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D000077146 | Irinotecan |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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